Catalog Number

B01-4137-01

Brand Name

ADVIA® Chemistry CKNAC Creatine Kinase Reagents

Version/Model Number

10341111

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2021

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K991576,K991576

Product Code

CGS

Product Code Name

NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Public Device Record Key

bbfbcc46-c7b9-44c8-b380-60612e01e34f

Public Version Date

December 02, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-